ELECSYS ANTI-TG TEST SYSTEM

K020672 · Roche Diagnostics Corp. · JZO · Aug 5, 2002 · Immunology

Device Facts

• Record ID: K020672
• Device Name: ELECSYS ANTI-TG TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: JZO · Immunology
• Decision Date: Aug 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Indications for Use

Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg determination is used as an aid in the detection of autoimmune thyroid disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.

Device Story

The ELECSYS Anti-Tg Assay is a two-step sandwich immunoassay utilizing streptavidin-coated microparticles and electrochemiluminescence (ECLIA) detection. It is designed for use on Roche Elecsys 1010/2010 and Modular Analytics E170 immunoassay analyzers in clinical laboratory settings. The device processes human serum or plasma samples; results are calculated via a calibration curve generated by a 2-point calibration and a master curve provided with the reagent barcode. Healthcare providers use the quantitative output to assist in the clinical diagnosis of autoimmune thyroid diseases. The system provides automated measurement, reducing manual processing requirements compared to traditional methods.

Clinical Evidence

Bench testing only. Performance evaluated using NCCLS EP5-A protocol. Reproducibility assessed over 10 days (n=59-60). Intra-assay precision (%CV) ranged from 4.6% to 5.6% for human serum samples. Total precision (%CV) ranged from 5.9% to 8.7%. Analytical sensitivity reported as < 10 IU/ml. Interference testing confirmed no significant interference from icterus (up to 66 mg/dL), hemolysis (up to 1.69 g/dL), lipemia (up to 2000 mg/dL triglyceride), biotin (up to 60 ng/mL), or rheumatoid factor (up to 300 U/mL).

Technological Characteristics

Two-step sandwich immunoassay; streptavidin-coated microparticles; electrochemiluminescence (ECLIA) detection. Calibrated against NIBSC 65/93 standard. Measuring range: 10–4000 IU/ml. Compatible with Elecsys 1010/2010 and Modular Analytics E170 analyzers. Reagent stability: 6 weeks on-board. Sample types: serum, heparinized plasma, K2/K3-EDTA plasma.

Indications for Use

Indicated for the quantitative determination of anti-thyroglobulin antibodies in human serum and plasma as an aid in the detection of autoimmune thyroid diseases.

Regulatory Classification

Identification

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

Predicate Devices

• Immulite 2000 Anti-TG Ab (K991094)

Submission Summary (Full Text)

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*020672

# 510(k) Summary - ELECSYS® Anti-Tg on ELECSYS® Immunoassay Analyzers

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br>Contact person: Sherri L. Coenen<br>Date prepared: February 27, 2002 |
| Device Name | Proprietary name: ELECSYS® Anti-Tg Assay<br>Common name: Antibodies to thyroglobulin (Anti-Tg)<br>Classification name: Thyroid autoantibody immunological test system |
| Device description | The ELECSYS® Anti-Tg Assay a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection.<br>Results are determined using a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code. |

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| Intended use | Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | The Anti-Tg determination is used as an aid in the detection of autoimmune thyroid diseases. |
| Substantial equivalence | The ELECSYS Anti-Tg test is equivalent to other devices legally marketed in the United States. We claim equivalence to the DPC Immulite 2000 Anti-TG AB (K991094). |

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The following table compares the ELECSYS® Anti-Tg, with the Predicate Substantial equivalence -Devices. similarities

| Feature | New Device<br>ELECSYS Anti-Tg | Predicate Device<br>Immulite 2000 Anti-TG Ab |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Immunoassay for the in vitro<br>determination of antibodies to<br>thyroglobulin in human serum<br>and plasma. The anti-Tg<br>determination is used as an aid<br>in the detection of autoimmune<br>thyroid diseases. The<br>electrochemiluminescence<br>immunoassay “ECLIA” is<br>intended for use on the Roche<br>Elecsys 1010/2010 and<br>Modular Analytics E170<br>immunoassay analyzers. | For in vitro diagnostic use with<br>the Immulite 2000 analyzer –<br>for the quantitative<br>measurement of autoantibodies<br>to thyroglobulin (TG) in serum<br>EDTA and heparinized<br>plasma, as an aid in the clinical<br>diagnosis of thyroid diseases. |
| Sample type | Human serum<br>Human plasma treated with<br>sodium heparin, or K2/K3-<br>EDTA | human serum, EDTA, and<br>heparinized plasma |
| Assay<br>Protocol | competitive assay | immunometric assay |
| Detection<br>Protocol | electrochemiluminescence<br>immunoassay | chemiluminescence assay |
| Traceability | Calibrated against NIBSC<br>65/93 Standard | Calibrated against NIBSC<br>65/93 Standard |

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Substantial equivalence differences

The following table compares the ELECSYS® Anti-Tg with the Predicate Device.

| Feature | New Device<br>ELECSYS Anti-Tg | Predicate Device<br>Immulite 2000 Anti-TG Ab |
|-----------------|-----------------------------------------------------------------------------|------------------------------------------------|
| Measuring range | 10 – 4000 IU/ml | 0 – 3000 IU/ml |
| Expected values | Up to 115 IU/ml (95th<br>percentile) | Nondetectable to 40 IU/ml<br>(95th percentile) |
| Instrument | ELECSYS® 2010, 1010,<br>and Modular Analytics E170<br>Immunoassay Analyzers | Immulite 2000 Analyzer |

#### Substantial equivalence performance characteristics

The performance characteristics of the ELECSYS Anti-Tg and the Predicate Device are compared in the table below.

Reproducibility was determined using Elecsys reagents, pooled human sera and commercial controls according to a modified protocol (EP5-A) of the NCCLS: five or six times daily for 10 days (n = 59 or 60); intra-assay precision on E170, n = 21. The following results were obtained:

| Feature | New Device<br>ELECSYS Anti-Tg | Predicate Device<br>Immulite 2000 Anti-TG Ab |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Intra-assay<br>precision (%CV) | Human Serum<br>• 4.9% at 62.8 IU/ml<br>• 5.1% at 115 IU/ml<br>• 4.6% at 290 IU/ml<br>• 5.6% at 2894 IU/ml<br>Controls<br>• 5.5% at 99.5 IU/ml<br>• 5.6% at 232 IU/ml | • 4.9% at 43 IU/ml<br>• 3.2% at 92 IU/ml<br>• 3.5% at 205 IU/ml<br>• 4.0% at 324 IU/ml<br>• 3.7% at 508 IU/ml<br>• 3.9% at 736 IU/ml |
| Total precision<br>(%CV) | Human Serum<br>• 8.7% at 62.8 IU/ml<br>• 7.2% at 115 IU/ml<br>• 5.9% at 290 IU/ml<br>• 6.3% at 2894 IU/ml<br>Controls<br>• 7.2% at 99.5 IU/ml<br>• 6.7% at 232 IU/ml | • 5.7% at 23 IU/ml<br>• 4.6% at 63 IU/ml<br>• 5.0% at 201 IU/ml<br>• 5.8% at 381 IU/ml<br>• 5.0% at 784 IU/ml<br>• 5.7% at 1644 IU/ml |

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Substantial equivalence performance characteristics, continued

The performance characteristics of the ELECSYS anti-Tg and the Predicate Device are compared in the table below.

| Feature | New Device<br>ELECSYS Anti-Tg | Predicate Device<br>Immulite 2000 Anti-TG Ab |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Analytical<br>sensitivity | < 10 IU/ml | 2.2 IU/ml |
| Limitations | No interference from icterus up to 66 mg/dL No interference from hemolysis up to 1.69 g/dL No interference from lipemia up to 2000 mg/dL triglyceride No interference from biotin up to 60 ng/mL No interference from rheumatoid factor up to 300 U/mL | No significant effect from bilirubin. No significant effect from hemolysis. |
| On-board<br>stability | Elecsys® 2010 / E170: 6 weeks Elecsys® 1010: 6 weeks (stored alternately in refrigerator and analyzer at ambient temperature 20-25 C) Up to 20 hr. opened in total | N/A |

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Substantial equivalence performance characteristics, continued

The performance characteristics of the ELECSYS Anti-Tg and the Predicate Device are compared in the table below.

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| Feature | | New Device | Predicate Device |
|-------------|---|-------------------------------------------------------------------------------------|--------------------------|
| | | ELECSYS Anti-Tg | Immulite 2000 Anti-TG Ab |
| Calibration | ● | Elecsys® 2010 / E170: | Every 2 weeks |
| frequency | | ● Once per reagent lot | |
| | | ● after one month (using<br>the same reagent lot) | |
| | | ● after 7 days (using the<br>same reagent kit on the<br>analyzer) | |
| | | ● Elecsys® 1010 | |
| | | ● With every reagent kit | |
| | | ● after 7 days (using the<br>same reagent kit,<br>ambient temperature 20<br>- 25°C) | |
| | | ● after 3 days (using the<br>same reagent kit,<br>ambient temperature 25<br>- 32°C) | |
| | | ● Controls out of range (both<br>systems) | |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, formed by three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image. The text is in all caps and is evenly spaced around the circle.

Food and Drug. Administration 2098 Gaither Road Rockville MD 20850 ·

Ms. Sherri L. Coenen Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

AUG 0 5 2002

Re: k020672

> Trade/Device Name: ELECSYS® Anti-Tg Assay Regulation Number: 21 CFR § 866.5870 Regulation Name: Thyroid Autoantibody Immunological Test System Regulatory Class: II Product Code: JZO Dated: May 9, 2002 Received: May 13, 2002

Dear Ms. Coenen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

: 上

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): N/A KO 20 6 7 2

Device Name: ELECSYS® Anti-Tg Test System

Indications For Use:

Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg determination is used as an aid in the detection of autoimmune thyroid disease.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V V ---------------------------------------------------------------------------------------------------------------------------------------------------------OR Over-The-Counter Use (Per 21 CFR 801.109)

(Optional Format 1-2-

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JP Rubio for G. Attain

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510(k) Number K020672